Planned Changes to UK Marketing Authorisations and the Impact on Product Packaging
The Windsor Framework (WF) is due to come into force on 1 January 2025 and sets out – amongst other measures – the long-term arrangements for the supply of medicines into Northern Ireland (NI); however, its implementation in this regard still remains subject to the UK providing certain written guarantees to the European Commission (per Article 8 of Regulation (EU) 2023/1182). These include assurances that UK medicinal products will not be moved into a Member State, that UK product packaging will not bear the specific EU features required by the Falsified Medicines Directive (FMD), and that UK supplies are clearly labelled as being for ‘UK Only’.
On 29 September 2023, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published new guidance on the changes to the licensing of human medicines across the UK (including Great Britain (GB) and NI) related to the planned implementation of the WF.
This guidance confirms that following its entry into force, the MHRA will have responsibility for licensing all medicinal products across the whole of the UK, including any new medicines that fall within the scope of the EU’s Centralised Procedure. After 31 December 2024, Marketing Authorisation Holders (MAH) can no longer apply for a stand-alone product licence for Great Britain (PLGB) and any new Marketing Authorisations (MA) will be assigned a national (UK-wide) ‘PL’ number.
In addition, from 1 January 2025, it will not be possible to simultaneously hold a PL and a PLGB or PLNI (Northern Ireland-only product licence) for the same medicinal product, and the following steps will be required, depending on the MAs that are currently held:
- MAH holds a PLGB only:
Existing PLGBs will automatically become valid for the whole of the UK on 1 January 2025 (unless the PLGB is cancelled prior to implementation of the WF). No MAH action is necessary to make this conversion; however, changes to the packaging will be required, as outlined below. Note that on ‘conversion’, the PLGB pre-fix will remain unchanged, even though the MA becomes valid UK-wide.
- MAH holds a parallel PLGB & PLNI:
If an MAH holds both a PLGB and a PLNI for the same product, and wishes to retain a UKwide MA, the PLNI should be cancelled/withdrawn by informing both the Reference Member State (RMS) for the relevant procedure and the MHRA. The deadline for notifying the MHRA is 30 September 2024. The remaining PLGB will then be converted to a UK-wide MA, as outlined above. If the MHRA does not receive a cancellation request for the PLNI, this will be retained, and MHRA will automatically cancel the PLGB. If the MAH wishes to retain its PLNI as part of an existing Mutual Recognition or Decentralised Procedure (MRP/DCP), the MAH may do so by cancelling the PLGB.
- MAH holds a PLNI only:
If the MAH holds a PLNI only but wishes to hold a UK-wide MA, the PLNI must be cancelled/withdrawn by informing the MHRA and the relevant RMS before the granting of the PL.
- MAH holds a UK-wide MA, granted via MRP/DCP:
If the MAH holds a pre-Brexit UK-wide MA (either MRP or DCP), where NI remains a Concerned Member State, the MA may continue in force after implementation of the WF, in full alignment with the EU product, until such time that UK-specific changes warrant the withdrawal of NI from the procedure. On removal of NI from the MRP/DCP procedure, the existing UK-wide MA would then be managed as a stand-alone PL across the whole of the UK.
On 29 September 2023, the MHRA also updated its guidance on the new labelling requirements, which will apply to UK-only medicinal products following the implementation of the WF on 1 January 2025, to preclude their onward movement into the EU. Stock already released onto the UK market (both GB and NI) before this date, may be supplied up until its expiry date.
‘UK Only’ label
To be allowed onto the UK market after implementation of the WF, all UK products (Prescription only, Pharmacy, and General Sales List) must bear the wording ‘UK Only’. The text must be conspicuous and clearly legible, printed in at least 7-point font, and in line with Article 5 of EU Regulation 2023/1182, current MHRA expectations and best practice guidance. There are no other specific font or style requirements. Implementation requirements and considerations are outlined below.
- Manufacturers may supply product to the UK in legacy EU packaging until 31 December 2024 (this represents a 1-year extension for GB-only products)
- MAHs must submit an MHRA application to introduce the ‘UK Only’ label. The latest date for submission of this change is 31 December 2024. For products with a UK-wide product licence, the MAH can introduce the ‘UK Only’ wording to the product pack immediately; however, the ‘UK Only’ label should not be applied to the packaging of any GB- or NI-only products until 1 January 2025.
- For a limited period (until 30 June 2025), and subject to QP certification, the ‘UK Only’ statement may be added by means of a sticker, which does not conceal any statutory text. Stickering will not be accepted after this date when the wording should be printed directly on the product pack.
- An application must be submitted to the MHRA by 31 December 2024, to introduce any labelling changes (including the placement of a sticker on the packaging, if used). MAHs may submit a self-certification notification, for which immediate implementation will be permitted, if the changes are in line with the guidance. Alternatively, MAHs may utilise any other regulatory opportunity (except Type IA variations) to introduce the change, ensuring that the update is adequately referenced in the cover letter. For this option, MAHs must await formal approval from the MHRA before implementation of the change. Bulk submissions are possible in the usual way.
- Early consideration should be given to any product supplies that currently rely on joint EU/UK packs, as from 1 January 2025, joint EU/UK packs cannot enter the supply chain and separate EU and ‘UK Only’ packs will be needed. Similarly, EU businesses currently supplied with a single UK English-language pack should ensure that provisions are in place to enable the continuation of EU supplies after implementation of the ‘UK Only’ pack.
Disapplication of the Falsified Medicines Directive
For prescription only medicines intended for supply into NI, EU FMD requirements will continue to apply until 1 January 2025. After this date, features specific to the FMD may be removed from product packaging; however, similar features (e.g., an alternative scannable data matrix code, serial number, and tamper evident packaging) may still be used, although this is not considered compulsory. The use of anti-tamper packaging is actively encouraged by the MHRA and the requirement for all other safety features (e.g., expiry dating) remains unchanged.
Note that from 1 January 2025, parallel import packs (PLPIs) will not require a ‘UK Only’ label to be applied, nor will PLPIs need to comply with the EU FMD requirements. Further MHRA guidance on the requirements for PLPIs is anticipated in due course.
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